Hysterectomy (surgical removal of the uterus) is performed on approximately 600,000 women annually in the United States. Hysterectomy is often the therapeutic choice for the treatment of uterine cancer, adenomyosis, menorrhagia, prolapse, dysfunctional uterine bleeding, and muscular tumors of the uterus, known as leimyoma or uterine fibroids.
However, a hysterectomy is a major surgical intrusion into a patient's body having attendant risks and many undesirable characteristics. Thus, any method which can provide the therapeutic result of a hysterectomy without removing the uterus would be a significant improvement in this field. Newer treatment methods have been developed for some uterine disorders to avoid removal of the patient's uterus.
For example, in 1995, it was demonstrated that uterine fibroids could be treated without hysterectomy using a non-surgical therapy, specifically comprising bilateral intraluminal occlusion of the uterine arteries (Ravina et al., “Arterial Embolization to Treat Uterine Myomata”, Lancet Sep. 9, 1995; Vol. 346; pp. 671-672, incorporated in its entirety herein). This technique is commonly known as “uterine artery embolization”. In this technique, uterine arteries are accessed by a delivery catheter via a transvascular route from a common femoral artery into the left and right uterine arteries and an embolization agent such as platinum coils or the like are deposition at a desired location within the uterine arteries. Thrombus quickly forms within the mass of platinum coils at the deployment site to occlude the artery.
The uterus has a dual (or redundant) blood supply, the primary blood supply being from the bilateral uterine arteries, and the secondary blood supply from the bilateral ovarian arteries. Consequently, when both uterine arteries are occluded, i.e. bilateral vessel occlusion, the uterus and the fibroids contained within the uterus are both deprived of their blood supply. However, as demonstrated by Ravina et al., the ischemic effect on the patient's fibroid is greater than the effect on the uterine tissue. In most instances, the uterine artery occlusion causes the fibroid to wither and cease to cause clinical symptoms.
However, many physicians do not possess the training or equipment necessary to perform catheter-based uterine artery embolization under radiologic direction. Accordingly, there are relatively few uterine artery embolizations performed each year in comparison to the number of hysterectomies that have been performed each year for uterine fibroids which are symptomatic.
What is needed, therefore, are simple procedures and the instruments for such procedures for occluding a female patient's uterine arteries without the undesirable features of a hysterectomy that can be used by physicians who do not have the training or equipment for intravascular uterine artery occlusion.